Clinical Trial: Staccato® Loxapine Treatment of Schizophrenic Patients With Agitation
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multi-Dose Efficacy and Safety Study of Staccato® Loxapine for Inhalation in Schizophrenic Patients With Agitat
Brief Summary: Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in schizophrenic patients
Detailed Summary: This is an in-clinic, multi-center, randomized, double-blind, placebo-controlled study of 2 dose levels of Staccato Loxapine, 5 and 10 mg. Patients may receive up to 3 doses of study drug in a 24-hour period, depending on their clinical status. The primary endpoint is the change from baseline in the PANSS (Positive and Negative Symptom Scale) Excited Component (also known as PEC) score, performed at 2 hours after the first dose.
Sponsor: Alexza Pharmaceuticals, Inc.
Current Primary Outcome: Change in PANSS Excited Component (PEC) score from baseline following Dose #1 of Staccato Loxapine, compared with placebo [ Time Frame: 2 hr ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Clinical Global Impression-Improvement (CGI-I) score following Dose #1 of Staccato Loxapine, compared with placebo [ Time Frame: 2 hr ]
- Treatment emergent adverse events, compared with placebo [ Time Frame: 24 hr ]
Original Secondary Outcome: Same as current
Information By: Alexza Pharmaceuticals, Inc.
Dates:
Date Received: February 25, 2008
Date Started: February 2008
Date Completion:
Last Updated: June 10, 2008
Last Verified: June 2008
